[Federal Register Volume 77, Number 44 (Tuesday, March 6, 2012)]
[Notices]
[Pages 13329-13336]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5312]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Office of the Secretary
Pandemic Influenza Vaccines--Amendment
ACTION: Notice of Amendment to the March 1, 2010 Republished
Declaration under the Public Readiness and Emergency Preparedness Act.
-----------------------------------------------------------------------
SUMMARY: Amendment to declaration issued on March 1, 2010 (75 FR 10268)
pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C.
247d-6d) to extend the effective time period, reformat the declaration,
modify or clarify terms of the declaration and republish the
declaration in its entirety, as amended.
DATES: The amendment of the republished declaration issued on March 1,
2010 is effective as of February 29, 2012.
FOR FURTHER INFORMATION CONTACT: Nicole Lurie, MD, MSPH, Assistant
[[Page 13330]]
Secretary for Preparedness and Response, Office of the Secretary,
Department of Health and Human Services, 200 Independence Avenue SW.,
Washington, DC 20201, Telephone (202) 205-2882 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
Background
The Public Readiness and Emergency Preparedness Act (``PREP Act'')
authorizes the Secretary of Health and Human Services (``the
Secretary'') to issue a declaration to provide liability immunity to
certain individuals and entities (``Covered Persons'') against any
claim of loss caused by, arising out of, relating to, or resulting from
the administration or use of medical countermeasures (``Covered
Countermeasures''), except for claims that meet the PREP Act's
definition of willful misconduct. Using this authority, the Secretary
issued a declaration for pandemic influenza vaccines, which has been
amended a number of times. The original pandemic influenza vaccine
declaration was published on January 26, 2007,\1\ and was amended on
November 21, 2007,\2\ October 17, 2008,\3\ June 15, 2009,\4\ September
28, 2009 \5\ and March 1, 2010.\6\ The March 1, 2010 amendment is
effective through February 28, 2012. The original declaration and its
amendments, as well as additional information about the PREP Act and
the Secretary's declarations for other medical countermeasures, can be
found here: http://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
---------------------------------------------------------------------------
\1\ 72 FR 4710 (2007).
\2\ 72 FR 67731 (2007).
\3\ 73 FR 61871 (2008).
\4\ 74 FR 30294 (2009).
\5\ 74 FR 51153 (2009).
\6\ 75 FR 10268 (2010).
---------------------------------------------------------------------------
The major actions taken by this pandemic influenza vaccine
declaration are the following: (1) Changing the format to make the
declaration easier for readers to follow; (2) clarifying that liability
immunity is provided not only to vaccines and adjuvants, but also to
vaccine components and constituent materials used as part of a covered
vaccine; (3) explicitly extending liability immunity to devices and
their constituent components used in the administration of vaccines,
e.g., needles (which provides for uniform coverage for devices,
regardless of whether they are manufactured or packaged with the
vaccine or combined later for administration by a healthcare provider);
(4) clarifying that liability immunity extends to recommended
activities related to any Federal agreements including e.g., clinical
trials agreements by adding the term ``other Federal agreements'' to
the clause describing the types of federal agreements for which
immunity is in effect; (5) narrowing the definition of
``administration'' to cover ``slip and fall'' claims only to the extent
they are directly tied to the operation of a countermeasure program;
and (6) extending the time period for which liability immunity is in
effect for the Covered Countermeasures to December 31, 2015. Other
modifications and clarifications are also made, as more fully explained
below.
The declaration is republished in full. We explain both the
substantive and format changes in this supplementary section.
The PREP Act was enacted on December 30, 2005 as Public Law 109-
148, Division C, section 2, 119 Stat 2818. It amended the Public Health
Service (``PHS'') Act, adding section 319F-3, which addresses liability
immunity, and section 319F-4, which creates a compensation program.
These sections are codified in the U.S. Code as 42 U.S.C. 247d-6d and
42 U.S.C. 247d-6e, respectively. Unless otherwise noted, all statutory
citations below are to the U.S. Code.
Section I, Determination of Public Health Emergency or Credible Risk of
Future Public Health Emergency
Before issuing a declaration under the PREP Act, the Secretary is
required to determine that a disease or other health condition or
threat to health constitutes a public health emergency or that there is
a credible risk that the disease, condition, or threat may in the
future constitute such an emergency.\7\ This determination is separate
and apart from a declaration issued by the Secretary under section 319
of the PHS Act, 42 U.S.C. 247d, that a disease or disorder presents a
public health emergency or that a public health emergency, including
significant outbreaks of infectious diseases or bioterrorist attacks,
otherwise exists, or other declarations or determinations made under
other authorities of the Secretary. In previous PREP Act declarations
(``declaration'' or ``declarations''), this determination appeared in
the declarations' introduction as the conclusion to the ``whereas''
clauses. The determination is now stated in the first section of the
declaration. This change was made to improve readability and is not
intended to have any substantive legal effect.
---------------------------------------------------------------------------
\7\ 42 U.S.C. 247d-6d(b)(1).
---------------------------------------------------------------------------
In addition, we made a substantive change to the determination. The
determination made in the ``whereas'' clauses in the March 1, 2010
declaration stated that the Secretary ``determined there is a credible
risk that the spread of pandemic influenza A viruses and those with
pandemic potential and resulting disease does or could constitute a
public health emergency.'' The Secretary is amending this
determination: (1) To substitute ``may in the future'' for ``could'' in
order to be consistent with the language used in the PREP Act \8\; and
(2) to remove the words ``the spread of'' and ``does or'' to clarify
that the 2009 H1N1 Influenza virus and resulting disease are not
currently causing a public health emergency. As discussed further in
section VI of this supplementary information section, we also changed
``and those'' to ``and influenza A viruses with'' for clarity. We also
specified that the viruses could potentially cause an influenza
pandemic . Thus, in this amended declaration, the Secretary determines
``that there is a credible risk that pandemic influenza A viruses and
influenza A viruses with pandemic potential could cause an influenza
pandemic with resulting disease that may in the future constitute a
public health emergency.''
---------------------------------------------------------------------------
\8\ See 42 U.S.C. 247d-6d(b)(1).
---------------------------------------------------------------------------
Section II, Factors Considered
In deciding whether and under what circumstances to issue a
declaration with respect to a Covered Countermeasure, the Secretary
must consider the desirability of encouraging the design, development,
clinical testing or investigation, manufacture, labeling, distribution,
formulation, packaging, marketing, promotion, sale, purchase, donation,
dispensing, prescribing, administration, licensing, and use of the
countermeasure.\9\ We previously stated these considerations in the
introductory ``whereas'' clauses to the declaration. The declaration
now states these considerations in section II. We made this change to
improve readability and do not intend that it have any substantive
legal effect.
---------------------------------------------------------------------------
\9\ 42 U.S.C. 247d-6d(b)(6).
---------------------------------------------------------------------------
Section III, Recommended Activities
The Secretary must recommend the activities for which the PREP
Act's liability immunity is in effect. These activities may include,
under conditions as the Secretary may specify, the manufacture,
testing, development, distribution, administration, or use of one or
more Covered Countermeasures
[[Page 13331]]
(``Recommended Activities'').\10\ In previous declarations, we included
the Recommended Activities in the introductory ``whereas'' clauses to
the declaration. The declaration now states them in section III. We
made this change to improve readability and do not intend that it have
any substantive legal effect.
---------------------------------------------------------------------------
\10\ 42 U.S.C. 247d-6d(b)(1).
---------------------------------------------------------------------------
Section IV, Liability Immunity
The Secretary must also state that liability protections available
under the PREP Act are in effect with respect to the Recommended
Activities.\11\ These liability protections provide that, ``[s]ubject
to other provisions of [the PREP Act], a covered person shall be immune
from suit and liability under Federal and State law with respect to all
claims for loss caused by, arising out of, relating to, or resulting
from the administration to or use by an individual of a covered
countermeasure if a declaration * * * has been issued with respect to
such countermeasure.'' \12\ In previous declarations, we included this
statement in section I of the declaration, entitled ``Covered
Countermeasures.'' The declaration now makes the statement that
liability immunity is in effect for Recommended Activities in a
separate section IV. We made this change to improve readability and do
not intend that it have any substantive legal effect.
---------------------------------------------------------------------------
\11\ 42 U.S.C. 247d-6d(b)(1).
\12\ 42 U.S.C. 247d-6d(a)(1).
---------------------------------------------------------------------------
Section V, Covered Persons
The PREP Act's liability immunity applies to ``Covered Persons''
with respect to administration or use of a Covered Countermeasure. The
term ``Covered Persons'' has a specific meaning, and is defined in the
PREP Act to include manufacturers, distributors, program planners, and
qualified persons, and their officials, agents, and employees, and the
United States.\13\ The PREP Act further defines the terms
``manufacturer,'' ``distributor,'' ``program planner,'' and ``qualified
person'' as described below.\14\
---------------------------------------------------------------------------
\13\ 42 U.S.C. 247d-6d (i)(2).
\14\ 42 U.S.C. 247d-6d(i).
A manufacturer includes a contractor or subcontractor of a
manufacturer; a supplier or licenser of any product, intellectual
property, service, research tool or component or other article used
in the design, development, clinical testing, investigation or
manufacturing of a Covered Countermeasure; and any or all of the
parents, subsidiaries, affiliates, successors, and assigns of a
manufacturer; \15\
---------------------------------------------------------------------------
\15\ 42 U.S.C. 247d-6d(i)(4).
---------------------------------------------------------------------------
A distributor means a person or entity engaged in the
distribution of drug, biologics, or devices, including but not
limited to: manufacturers; repackers; common carriers; contract
carriers; air carriers; own-label distributors; private-label
distributors; jobbers; brokers; warehouses and wholesale drug
warehouses; independent wholesale drug traders; and retail
pharmacies; \16\
---------------------------------------------------------------------------
\16\ 42 U.S.C. 247d-6d(i)(3).
---------------------------------------------------------------------------
A program planner means a State or local government, including
an Indian Tribe; a person employed by the State or local government;
or other person who supervises or administers a program with respect
to the administration, dispensing, distribution, provision, or use
of a Covered Countermeasure, including a person who establishes
requirements, provides policy guidance, or supplies technical or
scientific advice or assistance or provides a facility to administer
or use a Covered Countermeasure in accordance with the Secretary's
declaration; \17\ Under this definition, a private sector employer
or community group or other ``person'' can be a program planner when
it carries out the described activities.
---------------------------------------------------------------------------
\17\ 42 U.S.C. 247d-6d(i)(6).
---------------------------------------------------------------------------
A qualified person means a licensed health professional or other
individual who is authorized to prescribe, administer, or dispense
Covered Countermeasures under the law of the State in which the
countermeasure was prescribed, administered, or dispensed; or a
person within a category of persons identified as qualified in the
Secretary's declaration.\18\ Under this definition, the Secretary
can describe in the declaration other qualified persons, such as
volunteers, who are Covered Persons. Section V describes other
qualified persons covered by this declaration.
---------------------------------------------------------------------------
\18\ 42 U.S.C. 247d-6d(i)(8).
The PREP Act also defines the word ``person'' as used in the Act: a
person includes an individual, partnership, corporation, association,
entity, or public or private corporation, including a Federal, State,
or local government agency or department; \19\
---------------------------------------------------------------------------
\19\ 42 U.S.C. 247d-6d(i)(5).
---------------------------------------------------------------------------
The provisions regarding Covered Persons previously appeared as a
definition in section X, ``Definitions'' and as section VI, ``Other
Qualified Persons.'' We combined these two provisions into a new
section V, ``Covered Persons'' and added ``to perform an activity'' to
the description of ``Other Qualified Persons'' for clarity. We made
these changes to improve readability and clarity and do not intend them
to have any substantive legal effect.
Section VI, Covered Countermeasures
As noted above, section III describes the Secretary's Recommended
Activities for which liability immunity is in effect. This section
identifies the countermeasures for which the Secretary has recommended
such activities. The PREP Act states that a ``Covered Countermeasure''
must be: a ``qualified pandemic or epidemic product,'' or a ``security
countermeasure,'' as described immediately below; or a drug, biological
product or device authorized for emergency use in accordance with
section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).\20\
---------------------------------------------------------------------------
\20\ 42 U.S.C. 247d-6d(i)(1). Section 564 of the FD&C Act may be
found at 21 U.S.C. 360bbb-3.
---------------------------------------------------------------------------
A qualified pandemic or epidemic product means a drug or device, as
defined in the FD&C Act or a biological product, as defined in the PHS
Act \21\, that is: Manufactured, used, designed, developed, modified,
licensed or procured to diagnose, mitigate, prevent, treat, or cure a
pandemic or epidemic or limit the harm such a pandemic or epidemic
might otherwise cause; or manufactured, used, designed, developed,
modified, licensed, or procured to diagnose, mitigate, prevent, treat,
or cure a serious or life-threatening disease or condition caused by
such a drug, biological product or device.\22\
---------------------------------------------------------------------------
\21\ 21 U.S.C. 321(g)(1), (h); 42 U.S.C. 262(i)
\22\ 42 U.S.C. 247d-6d(i)(1)(A), (i)(7).
---------------------------------------------------------------------------
A security countermeasure is a drug or device, as defined in the
FD&C Act or a biological product, as defined in the PHS Act \23\ that:
The Secretary determines to be a priority to diagnose, mitigate,
prevent or treat harm from any biological, chemical, radiological, or
nuclear agent identified as a material threat by the Secretary of
Homeland Security, or to diagnose, mitigate, prevent, or treat harm
from a condition that may result in adverse health consequences or
death and may be caused by administering a drug, biological product, or
device against such an agent; and is determined by the Secretary of
Health and Human Services to be a necessary countermeasure to protect
public health.\24\
---------------------------------------------------------------------------
\23\ 21 U.S.C. 321(g)(1), (h);42 U.S.C. 262(i).
\24\ 42 U.S.C. 247d-6d(i)(1)(B),(c)(1)(B).
---------------------------------------------------------------------------
To be a Covered Countermeasure, qualified pandemic or epidemic
products and security countermeasures also must be approved or cleared
under the FD&C Act; \25\ licensed under the PHS Act; \26\ or authorized
for emergency use under the FD&C Act.\27\ In addition, a qualified
pandemic or epidemic product may be a Covered Countermeasure when it is
exempted under the FD&C Act for use as an investigational drug or
device \28\ that is the object of research for
[[Page 13332]]
possible use for diagnosis, mitigation, prevention, treatment, cure or
limit harm of a pandemic or epidemic or serious or life-threatening
condition caused by such a drug or device. A security countermeasure
also may be a Covered Countermeasure if it may reasonably be determined
to qualify for approval or licensing within eight years after the
Department's determination that procurement of the countermeasure is
appropriate.
---------------------------------------------------------------------------
\25\ 21 U.S.C. 301 et seq.
\26\ 42 U.S.C. 262.
\27\ 21 U.S.C. 360bbb-3.
\28\ 21 U.S.C. 355(i), 360j(g).
---------------------------------------------------------------------------
Provisions regarding Covered Countermeasures previously appeared in
section I of the declaration, ``Covered Countermeasures,'' and included
not only a description of the Covered Countermeasure but also
additional conditions characterizing countermeasures. We have
simplified this section so that it now only identifies the Covered
Countermeasures. We have relocated the other conditions previously
included in the ``Covered Countermeasure'' section to a new section,
``Limitations on Distribution,'' to improve readability. We do not
intend for this change to have any substantive legal effect.
We have also revised the definition of the Covered Countermeasure.
Previously, the declaration included in section X, ``Definitions,'' a
definition of the term ``Pandemic influenza A viruses and those with
pandemic potential.'' In this declaration, the Secretary defines the
Covered Countermeasures as ``vaccines against pandemic influenza A
viruses and influenza A viruses with pandemic potential.'' We replaced
the phrase ``and those'' with ``and influenza A'' before ``viruses with
pandemic potential'' to clarify that the declaration covers vaccines
only for influenza A viruses that have pandemic potential, not all
influenza viruses that have pandemic potential. This change is made
throughout the declaration wherever the phrase is used. We also changed
``and any associated adjuvants'' to ``and all components and
constituent materials of these vaccines'' to clarify the Secretary's
intent that all components and constituent materials, such as
preservatives, diluents, antibiotics as well as adjuvants are covered
as part of the vaccine. This change does not negatively affect the
Secretary's view that the manufacturer of an adjuvant used in a vaccine
qualifying as a covered countermeasure would qualify as a manufacturer
under this declaration and would be afforded the liability immunity
provided by the PREP Act. We also added ``and all devices and their
constituent components used in the administration of these vaccines''
to clarify that coverage extends to these devices when used in the
administration of these vaccines. Devices such as needles, syringes,
and aerosols, and their components and constituent materials are an
integral part of the administration of the vaccine. They are covered
regardless of whether they are manufactured or packaged with the
vaccine, or combined later for administration by a healthcare provider.
Finally, we added a statement referencing the statutory definitions of
Covered Countermeasures to indicate that certain statutory requirements
must also be met. These statutory requirements are discussed in the
first two paragraphs of this section of the preamble.
Finally, we moved language previously included in section VIII,
``Category of Disease, Health Condition, or Threat'' and modified
previous section VI, ``Covered Countermeasures,'' to provide that
vaccines (including any components and constituent materials and
devices used to administer vaccines) covered under the National Vaccine
Injury Compensation Program are not covered countermeasures under this
declaration. This language was moved from previous section X to section
VI to clarify the Secretary's determination concerning coverage of
vaccines under this declaration in the event that a strain of influenza
meeting the requirements set forth in section VIII is included in
vaccines covered by the National Vaccine Injury Compensation Program.
In such circumstances, such vaccines (those covered by the National
Vaccine Injury Compensation Program) would be automatically excluded
from this declaration. However, to the extent that the same strain of
influenza is included in other vaccines that are not covered by the
National Vaccine Injury Compensation Program, such vaccines could still
qualify as covered countermeasures under this declaration (assuming
they meet other requirements set forth in this declaration, including
the description of the disease, health condition, or threat set forth
in section VIII). Currently, the only types of influenza vaccines
covered by the National Vaccine Injury Compensation Program are
trivalent influenza vaccines. Thus, such vaccines are not covered by
this declaration. This modification is meant to clarify that
potentially one formulation of influenza vaccines (e.g., monovalent or
quadrivalent vaccines) could qualify as covered countermeasures under
this declaration (if such vaccines were not covered under the National
Vaccine Injury Compensation Program) and, at the same time, another
influenza vaccine containing the exact same strain of influenza virus
(e.g., a trivalent influenza vaccine) could be covered by the National
Vaccine Injury Compensation Program (and excluded from coverage under
this declaration).
Section VII, Limitations on Distribution
The Secretary may specify that liability immunity is in effect only
to Covered Countermeasures obtained through a particular means of
distribution.\29\ These limitations on distribution previously appeared
in section I, ``Covered Countermeasures,'' and section X,
``Definitions.'' We now state the limitations in a separate section and
combine them with relevant definitions for improved readability. The
declaration states that liability immunity is afforded to Covered
Persons for Recommended Activities related to:
---------------------------------------------------------------------------
\29\ 42 U.S.C. 247d-6d(a)(5), (b)(2)(E).
---------------------------------------------------------------------------
(a) Present or future Federal contracts, cooperative agreements,
grants, other transactions, interagency agreements, or memoranda of
understanding or other Federal agreements; or
(b) Activities authorized in accordance with the public health and
medical response of the Authority Having Jurisdiction to prescribe,
administer, deliver, distribute or dispense the pandemic
countermeasures following a declaration of an emergency.
For governmental program planners only, liability immunity is
afforded only to the extent they obtain Covered Countermeasures through
voluntary means, such as (1) donation; (2) commercial sale; (3)
deployment of Covered Countermeasures from Federal stockpiles; or (4)
deployment of donated, purchased, or otherwise voluntarily obtained
Covered Countermeasures from State, local, or private stockpiles.
In regard to (a), we added the phrase ``other transactions'', which
may be used for some Covered Countermeasure activities,\30\ and the
phrase ``or other Federal agreements'' to clarify that the provision is
intended to cover all types of Federal agreements. We changed the
conjunction ``and'' to ``or'' between (a) and (b) to clarify that
immunity is available under either of these circumstances; the
activities do not have to both relate to a Federal award or agreement
and be used in a public health and medical response in order for
immunity to apply. The conjunction ``and'' used in previous
declarations was a drafting error; the Secretary's intent in those
previous declarations has been the meaning conferred by the term
[[Page 13333]]
``or''. Provisions (a) and (b) are intended to afford immunity to
Federal government supported activities that precede a public health
emergency and to activities in accordance with all Authorities Having
Jurisdiction during a declared public health emergency.
---------------------------------------------------------------------------
\30\ See, e.g., 42 U.S.C. 247d-7d(c)(5).
---------------------------------------------------------------------------
In regard to (b), the meaning of the terms ``Authority Having
Jurisdiction'' and ``Declaration of an Emergency'' are unchanged.
Finally, we slightly modified the last limitation by deleting
extraneous statutory references and other language and by replacing the
final sentence with the word ``only'' after ``planners'' to improve
readability. We do not intend for the changes to this provision to
alter its substantive legal effect. As stated in the ``whereas''
clauses of the March 1, 2010 declaration, this limitation on
distribution is intended to deter program planners that are government
entities from seizing privately held stockpiles of Covered
Countermeasures. It does not apply to any other Covered Persons,
including other program planners who are not government entities.
Section VIII, Category of Disease, Health Condition, or Threat
The Secretary must identify, for each Covered Countermeasure, the
categories of diseases, health conditions, or threats to health for
which the Secretary recommends the administration or use of the
countermeasure.\31\ This information previously appeared in section II,
``Category of Disease,'' and in section X, ``Definitions.'' These
provisions now are combined into a single section to improve
readability. In addition, we replaced the description of the influenza
A virus as it previously appeared in section II with the term
``pandemic influenza A viruses and influenza A viruses with pandemic
potential'' and then followed that term with the definition that
previously appeared in section X. We made these changes to remove
redundancy and improve consistency and do not intend for it to alter
the substantive legal effect. Finally, we removed the phrase ``except
those included in seasonal influenza vaccines and/or covered under the
National Vaccine Injury Compensation Program'' from this section and
instead included similar language in section VI, for clarity as
described above.
---------------------------------------------------------------------------
\31\ 42 U.S.C. 247d-6d(b)(2)(A).
---------------------------------------------------------------------------
Section IX, Administration of Covered Countermeasures
The PREP Act does not explicitly define the term ``administration''
but does assign the Secretary the responsibility to provide relevant
conditions in the declaration. This definition previously appeared in
section X, ``Definitions.'' We have moved it to a separate section to
improve readability. The Secretary has also narrowed the definition of
``administration'' that was previously provided in the declaration. The
declaration previously defined the term ``administration'' to include
physical provision of a Covered Countermeasure, as well as management
and operation of systems and locations at which Covered Countermeasures
may be provided to recipients:
Administration of a Covered Countermeasure: As used in section
319F-3(a)(2)(B) of the Act includes, but is not limited to, public
and private delivery, distribution, and dispensing activities
relating to physical administration of the countermeasures to
recipients, management and operation of delivery systems, and
management and operation of distribution and dispensing locations.
The definition has been revised as follows:
Administration of a Covered Countermeasure: As used in section
319F-3(a)(2)(B) of the Act, means physical provision of the
countermeasures to recipients, or activities and decisions directly
relating to public and private delivery, distribution and dispensing
of the countermeasures to recipients; management and operation of
countermeasure programs; or management and operation of locations
for purpose of distributing and dispensing countermeasures.
As clarified, the definition of ``administration'' extends only to
physical provision of a countermeasure to a recipient, such as
vaccination or handing drugs to patients, and to activities related to
management and operation of programs and locations for providing
countermeasures to recipients, such as decisions and actions involving
security and queuing, but only insofar as those activities directly
relate to the countermeasure activities. Claims for which Covered
Persons are provided immunity under the Act are losses caused by,
arising out of, relating to, or resulting from the administration to or
use by an individual of a Covered Countermeasure consistent with the
terms of a declaration issued under the Act.\32\ Under the Secretary's
definition, these liability claims are precluded if the claims allege
an injury caused by physical provision of a countermeasure to a
recipient, or if the claims are directly due to conditions of delivery,
distribution, dispensing, or management and operation of countermeasure
programs at distribution and dispensing sites.
---------------------------------------------------------------------------
\32\ 42 U.S.C. 247d-6d(a).
---------------------------------------------------------------------------
Thus, it is the Secretary's interpretation that, when a declaration
is in effect, the Act precludes, for example, liability claims alleging
negligence by a manufacturer in creating a vaccine, or negligence by a
health care provider in prescribing the wrong dose, absent willful
misconduct. Likewise, the Act precludes a liability claim relating to
the management and operation of a countermeasure distribution program
or site, such as a slip-and-fall injury or vehicle collision by a
recipient receiving a countermeasure at a retail store serving as an
administration or dispensing location that alleges, for example, lax
security or chaotic crowd control. However, a liability claim alleging
an injury occurring at the site that was not directly related to the
countermeasure activities is not covered, such as a slip and fall with
no direct connection to the countermeasure's administration or use. In
each case, whether immunity is applicable will depend on the particular
facts and circumstances.
Section X, Population
The Secretary must identify, for each Covered Countermeasure
specified in a declaration, the population or populations of
individuals for which liability immunity is in effect with respect to
administration or use of the countermeasure.\33\ This section explains
which individuals should use the countermeasure or to whom the
countermeasure should be administered--in short, those who should be
vaccinated or take a drug or other countermeasure. These provisions
previously appeared in section IV, ``Population,'' and section X,
``Definitions,'' stating that the population included any person who
used or was administered a Covered Countermeasure: In a clinical trial
conducted or supported by the Federal Government; in a pre-pandemic
phase, or in a pandemic phase. We have amended the declaration to
provide that the population includes any individual who uses or who is
administered a Covered Countermeasure in accordance with the
declaration. We believe this broad statement accurately encompasses all
of the previously listed populations and ensures that no populations
that use or are administered the Covered Countermeasures in accordance
with the terms of the declaration are omitted, including those who use
or are administered the Covered Countermeasures in a post pandemic
[[Page 13334]]
phase during the disposition period, discussed below in section XII. We
deleted definitions of ``pre-pandemic phase'' and ``pandemic phase'' as
those descriptions and distinctions did not prove to be useful or
necessary in practice. These definitions presumed the first outbreak
would be outside of the United States, which will not necessarily be
the case.
---------------------------------------------------------------------------
\33\ 42 U.S.C. 247d-6d(b)(2)(C).
---------------------------------------------------------------------------
In addition, the PREP Act specifies that liability immunity is
afforded: (1) To manufacturers and distributors without regard to
whether the countermeasure is used by or administered to this
population; and (2) to program planners and qualified persons when the
countermeasure is either used by or administered to this population or
the program planner or qualified person reasonably could have believed
the recipient was in this population.\34\ We included these statutory
conditions in the declaration for clarity.
---------------------------------------------------------------------------
\34\ 42 U.S.C. 247d-6d(a)(4).
---------------------------------------------------------------------------
Section XI, Geographic Area
The Secretary must identify, for each Covered Countermeasure
specified in the declaration, the geographic area or areas for which
liability immunity is in effect with respect to administration or use
of the countermeasure, including, as appropriate, whether the
declaration applies only to individuals physically present in the area
or, in addition, applies to individuals who have a described connection
to the area.\35\ This section previously appeared in section V,
``Geographic Area.''
---------------------------------------------------------------------------
\35\ 42 U.S.C. 247d-6d(b)(2)(D).
---------------------------------------------------------------------------
In addition, the PREP Act specifies that liability immunity is
afforded: (1) To manufacturers and distributors without regard to
whether the countermeasure is used by or administered to individuals in
the geographic areas; and (2) to program planners and qualified persons
when the countermeasure is either used or administered in the
geographic areas or the program planner or qualified person reasonably
could have believed the countermeasure was used or administered in the
areas.\36\ We included these statutory conditions in the declaration
for clarity.
---------------------------------------------------------------------------
\36\ 42 U.S.C. 247d-6d(a)(4).
---------------------------------------------------------------------------
Section XII, Effective Time Period
The Secretary must identify, for each Covered Countermeasure, the
period or periods during which liability immunity is in effect,
designated by dates, milestones, or other description of events,
including factors specified in the PREP Act.\37\ This section
previously appeared as section III, ``Effective Time Period.''
---------------------------------------------------------------------------
\37\ 42 U.S.C. 246d-6d(b)(2)(B), (b)(6).
---------------------------------------------------------------------------
The declaration is amended to clarify when liability takes effect
for different distribution methods, and to extend the period for which
liability immunity is in effect. Rather than referring to the September
28, 2009 declaration as defining when the effective period commenced,
we have incorporated language from that declaration. We also clarified
that for any Covered Countermeasure that becomes covered under the
National Vaccine Injury Compensation Program after the declaration is
issued, liability immunity expires under the PREP Act immediately upon
such coverage. We made these changes for clarity and do not intend them
to have legal effect.
Section XIII, Additional Time Period of Coverage
The Secretary must specify a date after the ending date of the
effective period of the declaration that is reasonable for
manufacturers to arrange for disposition of the Covered Countermeasure,
including return of the product to the manufacturer, and for other
Covered Persons to take appropriate actions to limit administration or
use of the Covered Countermeasure.\38\ In addition, the PREP Act
specifies that for Covered Countermeasures that are subject to a
declaration at the time they are obtained for the Strategic National
Stockpile under 42 U.S.C. 247d-6b(a), the effective period of the
declaration extends through the time the countermeasure is used or
administered pursuant to a distribution or release from the Stockpile.
Liability immunity under the provisions of the PREP Act and the
conditions of the declaration continues during these additional time
periods. Thus, liability immunity is afforded during the ``Effective
Time Period,'' described under XII of the declaration, plus the
``Additional Time Period'' described under section XIII of the
declaration. The provision for additional time periods previously
appeared as section VII, ``Additional Time Periods of Coverage After
Expiration of the Declaration''. The provision is amended to clarify
the statutory provision that extended coverage applies to any products
obtained for the Strategic National Stockpile during the effective
period of the declaration. We included the statutory provision for
clarity.
---------------------------------------------------------------------------
\38\ 42 U.S.C. 247d-6d(b)(3).
---------------------------------------------------------------------------
Section XIV, Countermeasures Injury Compensation Program
Section 319F-4 of the PREP Act authorizes a Countermeasures Injury
Compensation Program (CICP) to provide benefits to eligible individuals
who sustain a serious physical injury or die as a direct result of the
administration or use of a Covered Countermeasure.\39\ Compensation
under the CICP for an injury directly caused by a Covered
Countermeasure is based on the requirements set forth in this
declaration, the administrative rules for the Program,\40\ and the
statute.\41\ To show direct causation between a Covered Countermeasure
and a serious physical injury, the statute requires ``compelling,
reliable, valid, medical and scientific evidence.'' \42\ The
administrative rules for the Program further explain the necessary
requirements for eligibility under the CICP. Please note that, by
statute, requirements for compensation under the CICP may not always
align with the requirements for liability immunity provided under the
PREP Act. This section previously appeared as section VIII,
``Compensation Fund.'' We have added language to explain the type of
injury and standard of evidence needed to be considered for
compensation under the CICP. We included this information for clarity.
---------------------------------------------------------------------------
\39\ 42 U.S.C. 247d-6e.
\40\ 42 CFR Part 110.
\41\ 42 U.S.C.247d-6e.
\42\ 42 U.S.C.247d-6e(b)(4).
---------------------------------------------------------------------------
Section XV, Amendments
The Secretary may amend any portion of a declaration through
publication in the Federal Register.\43\ This section previously
appeared in section IX, ``Amendments.'' The section has been updated to
reflect that this declaration amends the prior March 1, 2010
declaration and that the declaration incorporates all prior amendments.
---------------------------------------------------------------------------
\43\ 42 U.S.C. 247d-6d(b)(4).
---------------------------------------------------------------------------
Deleted Sections
The prior declaration contained a definitions section. These
definitions have been incorporated into the relevant sections of the
declaration as noted above, and modified or deleted where indicated
above.
An appendix previously appeared in the declaration that listed
Federal government contracts for research, development, and procurement
of Covered Countermeasures. We deleted this appendix to clarify that
liability immunity under the provisions of the PREP Act and terms of
the declaration is not limited to the contracts listed in
[[Page 13335]]
the appendix. Coverage is available for any award or agreement that
meets the description provided in section I of the declaration. In
addition, deleting the appendix relieves the Department of the need to
periodically update the appendix.
We made these deletions for clarity and do not intend them to have
legal effect.
Republished Declaration
Declaration, as Amended, for Public Readiness and Emergency
Preparedness Act Coverage for Vaccines Against Pandemic Influenza A
Viruses and Influenza A Viruses With Pandemic Potential
This declaration amends and republishes the March 1, 2010
Republished Declaration, as Amended, for coverage under the Public
Readiness and Emergency Preparedness (``PREP'') Act for Pandemic
Influenza Vaccines, 42 U.S.C. 247d-6d, 247d-6e. To the extent any term
of the March 1, 2010 Republished Declaration is inconsistent with any
provision of this Republished Declaration, the terms of this
Republished Declaration are controlling.
I. Determination of Public Health Emergency or Credible Risk of Future
Public Health Emergency
42 U.S.C. 247d-6d(b)(1)
I have determined that there is a credible risk that pandemic
influenza A viruses and influenza A viruses with pandemic potential
could cause an influenza pandemic with resulting disease that may in
the future constitute a public health emergency.
II. Factors Considered
42 U.S.C. 247d-6d(b)(6)
I have considered the desirability of encouraging the design,
development, clinical testing or investigation, manufacture, labeling,
distribution, formulation, packaging, marketing, promotion, sale,
purchase, donation, dispensing, prescribing, administration, licensing,
and use of the Covered Countermeasures.
III. Recommended Activities
42 U.S.C. 247d-6d(b)(1)
I recommend, under the conditions stated in this declaration, the
manufacture, testing, development, distribution, administration, or use
of the Covered Countermeasures.
IV. Liability Immunity
42 U.S.C. 247d-6d(a), 247d-6d(b)(1)
Liability immunity as prescribed in the PREP Act and conditions
stated in this declaration is in effect for the Recommended Activities
described in section III.
V. Covered Persons
42 U.S.C. 247d-6d(i)(2),(3),(4),(6),(8)(A) and (B)
Covered Persons who are afforded liability immunity under this
declaration are ``manufacturers,'' ``distributors,'' ``program
planners,'' ``qualified persons,'' and their officials, agents, and
employees, as those terms are defined in the PREP Act, and the United
States.
In addition, I have determined that the following additional
persons are qualified persons:
(a) Any person authorized in accordance with the public health
and medical emergency response of the Authority Having Jurisdiction,
as described in section VII below, to prescribe, administer,
deliver, distribute or dispense the Covered Countermeasures, and
their officials, agents, employees, contractors and volunteers,
following a declaration of an emergency;
(b) Any person authorized to prescribe, administer, or dispense
the Covered Countermeasures or who is otherwise authorized to
perform an activity under an Emergency Use Authorization in
accordance with section 564 of the Federal Food, Drug, and Cosmetic
Act (FD&C Act).
VI. Covered Countermeasures
42 U.S.C. 247d-6b(c)(1)(B), 42 U.S.C. 247d-6d(i)(1) and (7)
Covered Countermeasures are vaccines against pandemic influenza A
viruses and influenza A viruses with pandemic potential, all components
and constituent materials of these vaccines, and all devices and their
constituent components used in the administration of these vaccines,
except that influenza A vaccines and their associated components,
constituent materials and devices covered under the National Vaccine
Injury Compensation Program are not Covered Countermeasures.
Covered Countermeasures must be ``qualified pandemic or epidemic
products,'' or ``security countermeasures,'' or drugs, biological
products, or devices authorized for emergency use, as those terms are
defined in the PREP Act, the FD&C Act, and the Public Health Service
Act.
VII. Limitations on Distribution
42 U.S.C. 247d-6d(a)(5) and (b)(2)(E)
I have determined that liability immunity is afforded to Covered
Persons only for Recommended Activities involving Covered
Countermeasures that are related to:
(a) Present or future Federal contracts, cooperative agreements,
grants, other transactions, interagency agreements, memoranda of
understanding, or other Federal agreements;
or
(b) Activities authorized in accordance with the public health and
medical response of the Authority Having Jurisdiction to prescribe,
administer, deliver, distribute or dispense the Covered Countermeasures
following a declaration of an emergency.
i. The Authority Having Jurisdiction means the public agency or its
delegate that has legal responsibility and authority for responding to
an incident, based on political or geographical (e.g., city, county,
Tribal, State, or Federal boundary lines) or functional (e.g., law
enforcement, public health) range or sphere of authority.
ii. A declaration of emergency means any declaration by any
authorized local, regional, State, or Federal official of an emergency
specific to events that indicate an immediate need to administer and
use the Covered Countermeasures, with the exception of a Federal
declaration in support of an emergency use authorization under section
564 of the FD&C Act unless such declaration specifies otherwise;
I have also determined that for governmental program planners only,
liability immunity is afforded only to the extent such program planners
obtain Covered Countermeasures through voluntary means, such as (1)
donation; (2) commercial sale; (3) deployment of Covered
Countermeasures from Federal stockpiles; or (4) deployment of donated,
purchased, or otherwise voluntarily obtained Covered Countermeasures
from State, local, or private stockpiles.
VIII. Category of Disease, Health Condition, or Threat
42 U.S.C. 247d-6d(b)(2)(A)
The category of disease, health condition, or threat for which I
recommend the administration or use of the Covered Countermeasures is
the threat of or actual human influenza that results from the infection
of humans following exposure to pandemic influenza A viruses or
influenza A viruses with pandemic potential.
(a) Pandemic influenza A viruses and influenza A viruses with
pandemic potential mean: animal and/or human influenza A viruses that
are circulating in wild birds and/or domestic animals that cause or
have significant potential to cause sporadic or ongoing human
infections, or historically have caused pandemics in humans, or have
mutated to cause pandemics in humans, and for which the majority of the
population is immunologically na[iuml]ve.
[[Page 13336]]
(b)
IX. Administration of Covered Countermeasures
42 U.S.C. 247d-6d(a)(2)(B)
Administration of the Covered Countermeasure means physical
provision of the countermeasures to recipients, or activities and
decisions directly relating to public and private delivery,
distribution and dispensing of the countermeasures to recipients,
management and operation of countermeasure programs, or management and
operation of locations for purpose of distributing and dispensing
countermeasures.
X. Population
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(C)
The populations of individuals include any individual who uses or
is administered the Covered Countermeasures in accordance with this
declaration.
Liability immunity is afforded to manufacturers and distributors
without regard to whether the countermeasure is used by or administered
to this population; liability immunity is afforded to program planners
and qualified persons when the countermeasure is used by or
administered to this population or the program planner or qualified
person reasonably could have believed the recipient was in this
population.
XI. Geographic Area
42 U.S.C. 247d-6d(a)(4), 247d-6d(b)(2)(D)
Liability immunity is afforded for the administration or use of a
Covered Countermeasure without geographic limitation.
Liability immunity is afforded to manufacturers and distributors
without regard to whether the countermeasure is used by or administered
in these geographic areas; liability immunity is afforded to program
planners and qualified persons when the countermeasure is used by or
administered in these geographic areas, or the program planner or
qualified person reasonably could have believed the recipient was in
these geographic areas.
XII. Effective Time Period
42 U.S.C. 247d-6d(b)(2)(B)
For any Covered Countermeasure subsequently covered under the
National Vaccine Injury Compensation Program, liability immunity
expires immediately upon such coverage.
Liability immunity began June 15, 2009 for Covered Countermeasures
against the 2009 H1N1 pandemic influenza and is provided through
December 31, 2015 or until the Covered Countermeasure is covered under
the National Vaccine Injury Compensation Program, whichever occurs
first.
Liability immunity for countermeasures against other pandemic
influenza A viruses and influenza A viruses with pandemic potential for
means of distribution other than those in accordance with the public
health and medical response of the Authority Having Jurisdiction begins
on December 1, 2006 and lasts through December 31, 2015 or until the
Covered Countermeasure is covered under the National Vaccine Injury
Compensation Program, whichever occurs first.
Liability immunity for Covered Countermeasures against other
pandemic influenza A viruses or influenza A viruses with pandemic
potential administered or used in accordance with the public health and
medical response of the Authority Having Jurisdiction begins with a
declaration and lasts through: (1) The final day that the emergency
declaration is in effect, (2) December 31, 2015, or (3) until the
Covered Countermeasure is covered under the National Vaccine Injury
Compensation Program, whichever occurs first.
XIII. Additional Time Period of Coverage
42 U.S.C. 247d-6d(b)(3)(B) and (C)
I have determined that an additional twelve (12) months of
liability protection is reasonable to allow for the manufacturer(s) to
arrange for disposition of the Covered Countermeasure, including return
of the Covered Countermeasures to the manufacturer, and for Covered
Persons to take such other actions as are appropriate to limit the
administration or use of the Covered Countermeasures.
Covered Countermeasures obtained for the Strategic National
Stockpile (SNS) during the effective period of this declaration are
covered through the date of administration or use pursuant to a
distribution or release from the SNS.
XIV. Countermeasures Injury Compensation Program
42 U.S.C 247d-6e
The PREP Act authorizes a Countermeasures Injury Compensation
Program (CICP) to provide benefits to certain individuals who sustain a
serious physical covered injury as the direct result of the
administration or use of the Covered Countermeasures and benefits to
survivors or estates of individuals who die as a direct result of the
administration or use of the Covered Countermeasures. The causal
connection between the countermeasure and the serious physical injury
must be supported by compelling, reliable, valid, medical and
scientific evidence in order for the individual to be considered for
compensation. The CICP is administered by the Health Resources and
Services Administration (HRSA), within the Department of Health and
Human Services. Information about the CICP is available at the toll
free number 1-888-275-4772 or at http://www.hrsa.gov/countermeasurescomp/default.htm.
XV. Amendments
42 U.S.C. 247d-6d(b)(4)
The Declaration for the Use of the Public Readiness and Emergency
Preparedness Act for H5N1 was first published on January 26, 2007. That
declaration provided liability immunity for vaccines against H5N1
pandemic influenza under the terms and conditions stated in the
declaration. The declaration was amended on November 30, 2007 to add H7
and H9 vaccines; amended on October 17, 2008 to add H2 and H6 vaccines;
amended on June 15, 2009 to add 2009 H1N1 vaccines and republished in
its entirety; amended on September 28, 2009 to provide targeted
liability protections for pandemic countermeasures to enhance
distribution and to add provisions consistent with other declarations
and republished in its entirety; and amended on March 1, 2010 to revise
the Covered Countermeasures and extend the effective date and
republished in its entirety. This declaration incorporates all
amendments prior to the date of its publication in the Federal
Register.
Any further amendments to this declaration will be published in the
Federal Register.
Authority: 42 U.S.C. 247d-6d.
Dated: February 28, 2012.
Kathleen Sebelius,
Secretary.
[FR Doc. 2012-5312 Filed 3-5-12; 8:45 am]
BILLING CODE P